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Archives: Research Summaries

Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder

Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder

Journal: Neurology Neuroimmunology & Neuroinflammation; March 26, 2021

Author(s): Romain Marignier, Jeffrey L. Bennett, Ho Jin Kim, Brian G. Weinshenker, Sean J. Pittock, Dean Wingerchuk, Kazuko Fujihara, Friedemann Paul, Gary R. Cutter, Ari J. Green, Orhan Aktas, Hans-Peter Hartung, Fred D. Lublin, Ian M. Williams, Jorn Drappa, Dewei She, Daniel Cimbora, William Rees, Michael Smith, John N. Ratchford, Eliezer Katz, Bruce A.C. Cree

Clinical trial paper on the effect of inebilizumab on disability outcomes in NMOSD

This study (part of the N-MOmentum clinical trial) aimed to assess the effects of inebilizumab on the worsening of patients’ disability scores as measured by two scales — the Expanded Disability Status Scale (EDSS) and the modified Rankin Scale (mRS). The results showed that compared to placebo, inebilizumab reduced the risk of disability worsening over 3 months.

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Inebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder

Inebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder

Journal: CNS Drugs; September 7, 2022

Author(s): Tina Nie & Hannah A. Blair

A review of inebilizumab treatment in NMOSD

Inebilizumab is approved for use as an intravenous infusion for treatment of adult NMOSD patients who test positive for AQP4 antibodies. Clinical trials found inebilizumab more effective than placebo at preventing NMOSD relapses. It also prevented worsening of disability scores and decreased the number of NMOSD-related hospitalizations and MRI lesions. However, it did not significantly improve low-contrast binocular vision. The clinical benefit of inebilizumab was maintained long-term (≥ 4 years in the open-label extension of the clinical trial). Inebilizumab was generally well tolerated, with most adverse events being mild to moderate in severity. The most common adverse events were urinary tract infection and joint pain. Inebilizumab provides an effective option for preventing NMOSD attacks in adults who are aquaporin-4 (AQP4)-antibody seropositive.

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Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study

Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study

Journal: Multiple Sclerosis and Related Disorders; August 26, 2021

Author(s): Eoin P. Flanagan a, Michael Levy b, Eliezer Katz c, Daniel Cimbora c, Jorn Drappa c, Maureen A. Mealy c, Dewei She c, Bruce A.C. Cree

Effects of inebilizumab treatment in NMOSD patients who have previously been on rituximab

This study used data from the inebilizumab clinical trials (N-MOmentum trial) to assess whether the results achieved with this drug vary in any way for patients who have previously been on rituximab treatment. The results showed that inebilizumab had a comparable safety profile in participants with or without prior rituximab use and that patients with prior rituximab treatment did not have an increased risk of developing serious infections. Thus, inebilizumab may be a suitable treatment choice for individuals with neuromyelitis optica spectrum disorder who were previously treated with rituximab.

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Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4–immunoglobulin G–seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial

Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4–immunoglobulin G–seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial

Journal: Multiple Sclerosis Journal; October 1, 2021

Author(s): Mary Rensel, Aram Zabeti, Maureen A Mealy, Daniel Cimbora, Dewei She, Jorn Drappa, Eliezer Katz

Long-term efficacy and safety of inebilizumab in AQP4-positive NMOSD patients over at least 4 years

In this study, data from the inebilizumab clinical trials (N-MOmentum trial) was used to assess the outcomes for patients who had been receiving inebilizumbab for at least 4 years. The results continue to support use of inebilizumab for the treatment of NMOSD. The findings suggest that the efficacy of inebilizumab may be enhanced after the first year of treatment, and its effects should be studied over longer periods.

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Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder

Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder

Journal: The New England Journal of Medicine; November 28, 2019

Author(s): Takashi Yamamura, Ingo Kleiter, Kazuo Fujihara, Jacqueline Palace, Benjamin Greenberg, Beata Zakrzewska-Pniewska, Francesco Patti, Ching-Piao Tsai, Albert Saiz, Hayato Yamazaki, Yuichi Kawata, Padraig Wright, Jerome De Seze

Efficacy and safety of satralizumab combined with immunosuppressants in seropositive or seronegative NMOSD

This is a clinical trial paper of satralizumab, a recently approved therapy for NMOSD; the trial is known as the SAkuraSky trial. The efficacy and safety of satralizumab combined with stable immunosuppressant treatment was assessed in patients who tested positive or negative for were aquaporin 4 antibodies. During the first phase of the study, the enrolled patients were allowed to remain on their ongoing immunosuppressant therapy of azathioprine, mycophenolate mofetil, or oral glucocorticoids, to which satralizumab was added. Patients who had been on other immunosuppressants like rituximab during or up to 6 months before the trial initiation were not enrolled. 83 patients were randomly assigned to receive satralizumab (41 patients) or placebo (42 patients). The outcomes assessed were (a) the time to a relapse occurring after treatment, (b) changes in patients’ pain and fatigue. The results showed that among patients with NMOSD, satralizumab treatment added to immunosuppressant treatment. led to a lower risk of relapse than placebo but did not differ from placebo in its effect on pain or fatigue. The percentages of patients who had adverse events or serious adverse events associated with satralizumab were similar to those in the placebo group. However, there were more injection-site reactions and injection-related reactions in the satralizumab group than in the placebo group.

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Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial

Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial

Journal: The Lancet Neurology; May 1, 2020

Author(s): Anthony Traboulsee, Benjamin M Greenberg, Jeffrey L Bennett, Lech Szczechowski, Edward Fox, Svitlana Shkrobot, Takashi Yamamura, Yusuke Terada, Yuichi Kawata, Padraig Wright, Athos Gianella-Borradori, Hideki Garren, Brian G Weinshenker

Safety and efficacy of satralizumab treatment alone in NMOSD

In an earlier clinical trial study (called the SAkuraSky study), satralizumab combined with immunosuppressants was found to be effective in reducing NMOSD relapses. In this clinical trial study (called the SAkuraStar study), the efficacy and safety of satralizumab alone was assessed in NMOSD patients. This study was conducted on adult NMOSD patients (seropositive or seronegative) at 44 centers in 13 countries. 95 NMOSD patients were randomly assigned to receive satralizumab (without any other immunosuppressants) or placebo. The outcomes assessed were (a) the time to a relapse occurring after treatment, and (b) the occurrence of adverse events. The results showed that satralizumab monotherapy reduced the rate of NMOSD relapse compared with placebo; the incidence of serious adverse events and adverse events leading to treatment withdrawal was similar between patients who received satralizumab and placebo.

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Long-term Efficacy of Satralizumab in AQP4-IgG-Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar

Long-term Efficacy of Satralizumab in AQP4-IgG-Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar

Journal: Neurology Neuroimmunology & Neuroinflammation; December 8, 2022

Author(s): Ingo Kleiter, Anthony Traboulsee, Jacqueline Palace, Takashi Yamamura, Kazuo Fujihara, Albert Saiz, Adil Javed, David Mayes, H-Christian von Büdingen, Gaelle Klingelschmitt, Daniela Stokmaier, Jeffrey L Bennett

Long-term efficacy of satralizumab in NMOSD patients testing positive for aquaporin-4 antibodies

Two separate earlier clinical trials showed satralizumab to be efficacious in patients with seropositive or seronegative NMOSD, both when administered along with immunosuppressant therapy (known as the SAkuraSky study) and when administered alone (known as the SAkuraStar study). This study assessed the continued efficacy of satralizumab, with or without immunosuppressants, over more than 3.5 years in 103 of the AQP4-antibody seropositive patients from these earlier two studies. The results showed that the efficacy of satralizumab persisted over more than 3.5 years. High proportions of patients remained free from relapse, severe relapse, or worsening disease, with a consistently low annualized relapse rate.

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Long-term safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) from SAkuraSky and SAkuraStar

Long-term safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) from SAkuraSky and SAkuraStar

Journal: Multiple Sclerosis and Related Disorders; July 4, 2022

Author(s): Takashi Yamamura, Brian Weinshenker, Michael R Yeaman, Jerome De Seze, Francesco Patti, Patricia Lobo, H-Christian von Büdingen, Xiujing Kou, Kristina Weber, Benjamin Greenberg

Long-term safely of satralizumab in NMOSD patients testing positive for aquaporin-4 antibodies

Two separate earlier clinical trials showed satralizumab to be efficacious in patients with NMOSD, both when administered along with immunosuppressant therapy (known as the SAkuraSky study) and when administered alone (known as the SAkuraStar study). This study analyzed the long-term safety of satralizumab on the basis of data from the SAkuraSky and SAkuraStar studies (75 and 91 patients treated with satralizumab) over a period of 4 years or more. The findings showed that the safety profile of satralizumab (occurrence of adverse events, serious adverse events, infections, severe changes in laboratory markers, and deaths or anaphylactic reactions) remained the same over time, when administered alone or in combination with immunosuppressant therapy. No new safety concerns were observed in the extended study period versus the original clinical trial period.

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Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension

Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension

Journal: Multiple Sclerosis Journal; September 9, 2021

Author(s): Sean J Pittock, Kazuo Fujihara, Jacqueline Palace, Achim Berthele, Ho Jin Kim, Celia Oreja-Guevara, Ichiro Nakashima, Michael Levy, Shulian Shang, Marcus Yountz, Larisa Miller, Róisín Armstrong, Dean M Wingerchuk; PREVENT Study Group

Potential long-term benefits of eculizumab alone in NMOSD treatment

In the PREVENT clinical trial for eculizumab, a recently approved therapy for NMOSD, most patients received eculizumab along with immunosuppressant therapy. This study assessed the effects of eculizumab alone (monotherapy) on patients from the PREVENT study and its open-label extension (the phase of a trial where participants are aware what drug they are being administered). Of the PREVENT trial participants, 33 who were receiving eculizumab monotherapy were monitored for a median duration of 2.9 years (the duration ranging from 14 weeks to 5.2 years). All patients receiving eculizumab monotherapy remained relapse-free at week 96, versus 40% of those receiving placebo alone. At 192 weeks of eculizumab monotherapy, 96% of patients were relapse-free. During the PREVENT study, 95% of patients receiving eculizumab monotherapy showed no worsening in disability and greater quality of life improvements versus placebo alone. Since this study involved only 33 patients who were followed for a wide range of durations, these findings only point to the potential long-term benefits of eculizumab monotherapy. Additional studies are needed to validate these findings and how long the potential benefits last.

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Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder

Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder

Journal: The New England Journal of Medicine; August 15, 2019

Author(s): Sean J Pittock, Achim Berthele, Kazuo Fujihara, Ho Jin Kim, Michael Levy, Jacqueline Palace, Ichiro Nakashima, Murat Terzi, Natalia Totolyan, Shanthi Viswanathan, Kai-Chen Wang, Amy Pace, Kenji P Fujita, Róisín Armstrong, Dean M Wingerchuk

Clinical trial of eculizumab treatment in NMOSD patients testing positive for aquaporin-4 antibodies

In this clinical trial called the PREVENT study, 143 patients were randomly assigned to receive either eculizumab or placebo in a 2:1 ratio (2 patients on eculizumab for every 1 on placebo). Patients were allowed to continue receiving immunosuppressants such as azathioprine if they were already on them. However, patients who had been receiving rituximab or mitoxantrone at the time of recruitment or up to 3 months prior were not allowed to participate. Patients were vaccinated against Neisseria meningitidis. The effects of eculizumab were assessed in terms of time to first relapse after treatment, annualized relapse rate, changes in disability scores, and quality of life. Safety assessments included monitoring for adverse events, evaluation of vital signs, a physical examination, electrocardiography and clinical laboratory tests, and evaluation for the presence of suicidal ideation or behavior. The results showed that among patients with AQP4-IgG–positive NMOSD, those who received eculizumab had a significantly lower risk of relapse than those who received placebo.

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